Effect of Artificially Sweetened Beverages on Diabetes Control in Adults with Type 2 Diabetes

项目摘要 添加人工甜味剂（AS）的减肥饮料在食品中占有独特的类别 因为它们是没有热量或营养的强烈甜味的来源。减肥饮料是 美国饮食中AS摄入量的最大贡献者，饮食饮料的消费量显着增加 在过去30多年里，随着肥胖和2型糖尿病的双重流行，糖尿病发病率有所增加。一 新兴的基础、临床和人口研究表明，减肥饮料与 肥胖、肾功能下降、代谢综合征、2型糖尿病和 心血管疾病其他发展中的研究表明，饮食饮料和AS， 它们可能会改变肠道激素、肠道微生物组、口味偏好、饱腹感和整体饮食摄入量， 提供了可能改变疾病风险的合理机制。这些初步报告以及相关报告 夸张的媒体报道，引发了科学和公众对减肥饮料可能 玩健康。尽管这一知识框架正在萌芽，但证据基础在很大程度上没有得到以下信息： 随机临床试验测试饮食饮料的摄入是否影响临床风险的测量。 此外，这一主题的一个核心问题是缺乏针对患有 糖尿病患者可能是饮食饮料摄入量最重要的人群。糖尿病患者 是饮食饮料的最高消费者，倾向于消费它们作为饮食来源的替代品， 糖，特别是代替含糖饮料。这种行为得到了dietetic和 科学组织和饮食饮料作为更好的健康的同义词销售，适合于 体重减轻，因此有利于糖尿病控制。潜在的公共卫生问题是， 很少有数据支持或反驳习惯性饮食饮料消费的人的益处或危害， 糖尿病为了开始解决这一重要的科学差距，我们建议测试减肥饮料的效果 一项随机、两组研究中自由生活的2型糖尿病成年患者的糖尿病控制参数 平行试验，导入期2周，积极干预期12周。我们将招募240名 2型糖尿病患者，他们通常是商业饮食饮料的消费者，并将他们随机分配到 接受和消费：1）选择商业饮食饮料（3份或24盎司。每日）;或2） 原味瓶装水（起泡或普通）（3份或24盎司）每日）。主要结果将是 糖化血红蛋白（HbA 1c）是临床糖尿病控制的中心指标，我们还将测量 心脏代谢风险和肾功能。此外，我们将测量合理的机制， 通过评估饮食饮料摄入量对功能性成分的影响， 肠道微生物组以及通常的饮食摄入量，食欲和口味偏好。

PROJECT SUMMARY Diet beverages sweetened with artificial sweeteners (AS) occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories or nutrients. Diet beverages are the single largest contributor to AS intake in the U.S. diet, and consumption of diet beverages has significantly increased over the past 30 plus years in concert with the twin epidemics of obesity and type 2 diabetes. A burgeoning body of basic, clinical, and population research suggests that diet beverages are linked with obesity, decline in kidney function, and increased risk of metabolic syndrome, type 2 diabetes, and cardiovascular disease. Other developing research has suggested diet beverages and the AS that sweeten them may alter gut hormones, the gut microbiome, taste preferences, satiety, and overall dietary intake, thus providing plausible mechanisms whereby disease risk may be altered. These initial reports, and related hyperbolic media coverage, have sparked both scientific and public interest in the role that diet beverages may play in health. Despite this budding framework of knowledge, the evidence base is largely uninformed by randomized clinical trials testing whether intake of diet beverages impacts measures of clinical risk. Furthermore, an issue central to this topic is the lack of research addressing the population with diabetes, perhaps the most important population with respect to diet beverage intake. People with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes. To begin addressing this important scientific gap we propose to test the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 12-weeks. We will recruit 240 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c), and we will also measure cardiometabolic risk and kidney function. Additionally, we will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome as well as usual dietary intake, appetite, and taste preferences.